Subcutaneous Implant Combination Product (AUR-201) in Patients With Unilateral Microtia (Australia)

NCT06225336 | Terminated Phase 1 DMC

• 1 other identifier: AUR-201-02
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

AUR-201 is indicated for the treatment of Grade II, III, or IV unilateral microtia in patients 8 to 29 years of age.

Conditions

Microtia

Outcome Measures

Primary Outcomes (2)

• Incidence of Treatment-Emergent Adverse Events

  To assess the safety and tolerability of AUR-201 in patients with unilateral microtia based on Incidence of Treatment-Emergent Adverse Events from the time of biopsy sample collection of auricular cartilage from the contralateral (non-microtic) ear through 24 weeks post-implantation of AUR-201. The severity of AEs will be graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.

  24 weeks

• Appearance/Efficacy of the AUR-201 Implant

  To assess the efficacy of AUR-201 in patients with unilateral microtia based on improvement in overall appearance at 24 weeks post-implantation compared to pre-implantation baseline as determined by review and rating of photographs on a 5-point Likert scale by a panel of blinded independent experts. (All scores are based on a 5-point Likert scores and are represented as follows: 1 = Poor, 2=Fair, 3=Good, 4= Very Good and 5=Excellent)

  24 weeks

Study Arms (1)

AUR-201

EXPERIMENTAL

AUR-201

Combination Product: AUR-201

Interventions

AUR-201 COMBINATION_PRODUCT

Auricle and wedge subcutaneous implant consisting of 3-D printed autologous auricular sourced chondrocytes in a biopolymer matrix.

AUR-201

Eligibility Criteria

• Age: 8 Years - 29 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Child between 8 and 17 years of age (inclusive) at the time the guardian signs the ICF or adult between 18 and 29 years of age (inclusive) at the time of signing the ICF. Note, the implantations of AUR-201 will initially be staggered based on age and completion of specified DSMB evaluations (see Methodology section);
• Diagnosed with Grade II, III, or IV congenital unilateral microtia requiring complete auricular reconstruction;
• Naïve to microtia surgery or have had prior failed microtia surgery not involving the TPF flap;
• Able and willing to adhere to the post-operative wound care instructions (including, but not limited to, wearing protective devices specified by the PI) and the protocol-specified follow-up schedule;
• Willing to refrain from non-contact sports and contact sports (e.g., football, soccer, rugby, boxing, karate) for 6 and 12 weeks, respectively, following the first implantation surgery, or longer if deemed necessary for healing by the PI. If the PI opts to implant the AUR-201 wedge at a separate subcutaneous location on Day 0 and then 12 weeks later, implants the wedge in the final location, these periods of refraining from non-contact and contact sports will also apply to the second implantation surgery;
• PI deems the subject an appropriate candidate for the planned AUR-201 biopsy and implantation procedures (i.e., either the TPF flap technique or the pocket technique) and that the subject meets the following criteria:
• Healthy auricular cartilage donor site (e.g., conchal bowl site) on contralateral (non-microtic) ear available for biopsy;
• Healthy skin tissue at site of planned microtia repair;
• Healthy (other than for microtia) as determined by the PI based on medical history, physical examinations, body weight, vital signs, 12-lead electrocardiogram (ECG), and safety laboratory tests at screening/pre-biopsy baseline;
• Negative test results for human immunodeficiency virus 1 (HIV-1), human immunodeficiency virus 2 (HIV-2), hepatitis B virus (HBV), hepatitis C virus (HCV), Treponema pallidum (i.e., syphilis), and West Nile virus 1 (WNV-1) within seven days prior to the biopsy for harvesting auricular cartilage from the contralateral ear;
• Able to understand the English language;
• Subject or guardian able to understand the ICF and give informed consent/assent;
• Subject or guardian signed the ICFs for both this study (Protocol No. AUR-201-02) and the long-term follow-up (LTFU) study (Protocol No. AUR-201-04);
• Women of childbearing potential (WCBP) must have a negative serum pregnancy test at screening and a negative urine pregnancy test at the pre-biopsy baseline visit;
• WCBP must agree to abstain from sex or use an adequate method of contraception\* from the time of informed consent through the last study visit at 96 weeks post-implantation;

You may not qualify if:

• Any comorbidities likely to affect healing or the ability to adhere to the protocol, including:
• Burns, trauma, problematic wound healing, or scarring skin malformations at the planned site of microtia repair or the planned site of biopsy collection for auricular cartilage;
• Squamous cell carcinoma, basal cell carcinoma, or melanoma at the planned site of microtia repair or the planned site of biopsy collection for auricular cartilage;
• Uncontrolled diabetes or hypertension;
• History of diabetes requiring amputation or dialysis;
• Serious autoimmune disorder, or ongoing immunocompromised state;
• Current or recent history (within four weeks prior to initial screening visit) of a clinically significant bacterial, fungal, or mycobacterial infection;
• Current clinically significant viral infection;
• History of human transmissible spongiform encephalopathies (TSEs), including Creutzfeldt-Jakob disease;
• History of Zika virus infection;
• Completed treatment of syphilis within 12 months prior to screening;
• Uncontrolled acne vulgaris in the area of the planned AUR-201 implantation site;
• History of organ transplant;
• Major cardiac, pulmonary, renal, hepatic, metabolic, neurologic, or urologic disorders;
• Predisposition or history of keloid or hypertrophic scar development;

Sponsors & Collaborators

• Auregen Biotherapeutics, SA: lead

Study Sites (1)

Chris O'Brien Lifehouse

Camperdown, 2050, Australia

Location

MeSH Terms

Conditions

Congenital Microtia

Condition Hierarchy (Ancestors)

Ear Diseases; Otorhinolaryngologic Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Joseph Dusseldorp, MD

  Chris O'Brien Lifehouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2024
• First Posted: January 25, 2024
• Study Start: November 4, 2022
• Primary Completion: September 10, 2025
• Study Completion: September 10, 2025
• Last Updated: November 19, 2025

Record last verified: 2025-11

Locations

AU (1)